510(k) Report

Devices descending from K925465

18 later devices reach Teleradiology Device & Component of Pacs Component through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050906Vitalcare I.V. Administration SetVitalcare Group, Inc.200517—
+2K121511Maclin Power Intravascular Administration SetMaclin Power, Inc.20130—
+2K111351Truecare Biomedix Intravascular Administration Set, Truecare Biomedix Extension SetUs Infusion Dba Truecare Biomedix20117—
+2K092715Iroot BP PlusInnovative Bioceramix, Inc.20097—
+3K251465Root canal repair materials (nRoot BP)Enpuno Biotechnology Co., Ltd.20250—
+3K240365Bioceramic Root Repair Material (C-Root BP)Beijing C-Root Dental Medical Devices Co., Ltd.20241—
+3K232299CeraPuttyMeta Biomed Co., Ltd.20230—
+3K223645I.V. Administration Set, I.V. Extension SetBq Plus Medical Co., Ltd.20230—
+3K222992iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material…Innovative Bioceramix, Inc.20220—
+3K121803Intravascular Administration SetActa Medical, LLC20124—
+3K112863Enteral Administration Set with Solution Container, Enteral Administration Set, Enteral…Acta Medical, LLC20120—
+3K102867Iroot FSInnovative Bioceramix, Inc.20102—
+4K242934Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP)Longly Biotechnology (Wuhan) Co., Ltd.20240—
+4K230992DJF Intravascular Administration SetYangzhou Wei DE LI Trade Co., Ltd.20230—
+4K213757Endocem MTA Premixed RegularMaruchi20230—
+4K210381I.V. Administration SetBq Plus Medical Co., Ltd.20210—
+4K162601Infusion Set for Single UseShinva Ande Healthcare Apparatus Co., Ltd.20170—
+4K150513Imed Technology Intravascular Administration Set, Imed Technology Extension SetImed Technology, Inc.20150—